Effect of an Herbal-Based Injection on 28-Day Mortality in Patients With Sepsis

Author:

Liu Songqiao1,Yao Chen2,Xie Jianfeng1,Liu Hong3,Wang Hongliang4,Lin Zhaofen5,Qin Bingyu6,Wang Difen7,Lu Weihua8,Ma Xiaochun9,Liu Yan10,Liu Ling1,Zhang Chi11,Xu Lei12,Zheng Ruiqiang13,Zhou Feihu14,Liu Zhongmin15,Zhang Guoqiang16,Zhou Lixin17,Liu Jian18,Fei Aihua19,Zhang Guoxiu20,Zhu Yimin21,Qian Kejian22,Wang Ruilan23,Liang Yafeng24,Duan Meili25,Wu Dawei26,Sun Rongqing27,Wang Ying28,Zhang Xijing29,Cao Quan30,Yang Mingshi31,Jin Minggen32,Song Yan33,Huang Ling34,Zhou Fachun35,Chen Dechang36,Liang Qun37,Qian Chuanyun38,Tang Zhongzhi39,Zhang Zhong40,Feng Qiming41,Peng Zhiyong42,Sun Renhua43,Song Zhenju44,Sun Yunbo45,Chai Yanfen46,Zhou Lihua47,Cheng Chen48,Li Li49,Yan Xiaoyan2,Zhang Junhua50,Huang Yingzi1,Guo Fengmei1,Li Chuan48,Yang Yi1,Shang Hongcai10,Qiu Haibo1,Liu Wenxue51,Shang Meixia51,Han Jibin51,Li Ming51,Ma Linhao51,Li Yunpeng51,Liu Yuanyi51,Yu Tao51,Li Xin51,Lu Xing51,Chen Qihong51,Yang Yimin51,Li Yan51,Guo Weiguang51,Dou Zhimin51,Gao Chengjin51,Li Dahuan51,Han Xiaotong51,Shao Qiang51,Xie Yun51,Li Xiaoli51,Lin Jin51,Li Zhi51,Gao Min51,Song Yunxi51,Su Binxiao51,Liu Yun51,Peng Yue51,Cui Qingsong51,Yu Huichao51,Fu Baocai51,Lin Shihui51,Huang Yanxia51,Cao Xuedan51,Wang Xiao51,Fang Qing51,Huang Ruolan51,Yang Kaichao51,Feng Ying51,Gong Fangxiao51,Yin Jun51,Cai Shixia51,Li Shixin51,Wang Jingchao51,Zheng Wenke51,

Affiliation:

1. Jiangsu Provincial Key Laboratory of Critical Care Medicine, Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, Jiangsu, China

2. Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China

3. Department of Critical Care Medicine, The First Hospital of Shanxi Medical University, Taiyuan, Shanxi, China

4. Department of Critical Care Medicine, The Second Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China

5. Department of Emergency and Critical Care, Shanghai Changzheng Hospital, Shanghai, China

6. Department of Critical Care Medicine, Henan Provincial People’s Hospital, Zhengzhou, Henan, China

7. Department of Critical Care Medicine, The Affiliated Hospital of Guizhou Medical University, Guiyang, Guizhou, China

8. Department of Critical Care Medicine, Yijishan Hospital, The First Affiliated Hospital of Wannan Medical College, Wuhu, Anhui, China

9. Department of Critical Care Medicine, The First Affiliated Hospital, China Medical University, Shenyang, Liaoning, China

10. Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China

11. Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China

12. Department of Critical Care Medicine, Tianjin Third Central Hospital, Tianjin, China

13. Department of Critical Care Medicine, Northern Jiangsu People’s Hospital, Yangzhou, Jiangsu, China

14. Department of Critical Care Medicine, Chinese PLA General Hospital, Beijing, China

15. Department of Critical Care Medicine, The First Hospital of Jilin University, Changchun, Jilin, China

16. Department of Emergency, China-Japan Friendship Hospital, Beijing, China

17. Department of Critical Care Medicine, First People’s Hospital of Foshan, Foshan, Guangdong, China

18. Department of Critical Care Medicine, The First Hospital of Lanzhou University, Lanzhou, Gansu, China

19. Department of Emergency, Xinhua Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China

20. Department of Emergency, The First Affiliated Hospital of Henan Science and Technology University, Luoyang, Henan, China

21. Hunan Provincial Institute of Emergency Medicine, Hunan Provincial People’s Hospital, Changsha, Hunan, China

22. Department of Critical Care Medicine, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China

23. Department of Emergency, Shanghai General Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China

24. Department of Critical Care Medicine, Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, China

25. Department of Critical Care Medicine, Beijing Friendship Hospital, Capital Medical University, Beijing, China

26. Department of Critical Care Medicine, Qilu Hospital of Shandong University (Qingdao), Qingdao, Shandong, China

27. Department of Critical Care Medicine, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China

28. Department of Respiration, Chinese PLA General Hospital of Rocket Forces, Beijing, China

29. Department of Anesthesiology, Xijing Hospital, Xi'an, Shaanxi, China

30. Department of Critical Care Medicine, Jiangsu Province Hospital, Nanjing, Jiangsu, China

31. Department of Critical Care Medicine, The Third Xiangya Hospital of Central South University, Changsha, Hunan, China

32. Department of Critical Care Medicine, Yanbian University Hospital, Yanji, Jilin, China

33. Department of Critical Care Medicine, Central Hospital of Shenyang Medical College, Shenyang, Liaoning, China

34. Department of Critical Care Medicine, Yantaishan Hospital, Yantai, Shandong, China

35. Department of Critical Care Medicine, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China

36. Department of Critical Care Medicine, Ruijin North Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China

37. Department of Critical Care Medicine, First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, Heilongjiang, China

38. Department of Emergency, First Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China

39. Department of Emergency, Chinese PLA Wuhan General Hospital, Wuhan, Hubei, China

40. Department of Critical Care Medicine, Shenzhen Traditional Chinese Medicine Hospital, Shenzhen, Guangdong, China

41. Department of Emergency, Shanghai Sixth People’s Hospital, Shanghai, China

42. Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China

43. Department of Critical Care Medicine, Zhejiang Provincial People’s Hospital, Hangzhou, Zhejiang, China

44. Department of Emergency, Zhongshan Hospital, Fudan University, Shanghai, China

45. Department of Critical Care Medicine, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China

46. Department of Emergency, Tianjin Medical University General Hospital, Tianjin, China

47. Department of Critical Care Medicine, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, China

48. State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Zhangjiang Hi-Tech Park, Shanghai, China

49. First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin, China

50. Evidence-Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin, China

51. for the EXIT-SEP Investigators

Abstract

ImportancePrevious research has suggested that Xuebijing injection (XBJ), an herbal-based intravenous preparation, may reduce mortality among patients with sepsis.ObjectiveTo determine the effect of XBJ vs placebo on 28-day mortality among patients with sepsis.Design, Setting, and ParticipantsThe Efficacy of Xuebijing Injection in Patients With Sepsis (EXIT-SEP) trial was a multicenter, randomized double-blind, placebo-controlled trial conducted in intensive care units at 45 sites and included 1817 randomized patients with sepsis (sepsis 3.0) present for less than 48 hours. Patients aged 18 to 75 years with a Sequential Organ Failure Assessment score of 2 to 13 were enrolled. The study was conducted from October 2017 to June 2019. The final date of follow-up was July 26, 2019. Data analysis was performed from January 2020 to August 2022.InterventionsThe patients were randomized to receive either intravenous infusion of XBJ (100 mL, n = 911) or volume-matched saline placebo (n = 906) every 12 hours for 5 days.Main Outcomes and MeasuresThe primary outcome was 28-day mortality.ResultsAmong the 1817 patients who were randomized (mean [SD] age, 56.5 [13.5] years; 1199 [66.0%] men), 1760 (96.9%) completed the trial. In these patients, the 28-day mortality rate was significantly different between the placebo group and the XBJ group (230 of 882 patients [26.1%] vs 165 of 878 patients [18.8%], respectively; P < .001). The absolute risk difference was 7.3 (95% CI, 3.4-11.2) percentage points. The incidence of adverse events was 222 of 878 patients (25.3%) in the placebo group and 200 of 872 patients (22.9%) in the XBJ group.Conclusions and RelevanceIn this randomized clinical trial among patients with sepsis, the administration of XBJ reduced 28-day mortality compared with placebo.Trial RegistrationClinicalTrials.gov Identifier: NCT03238742

Publisher

American Medical Association (AMA)

Subject

Internal Medicine

全球学者库

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"全球学者库"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前全球学者库共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2023 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3